Abstract 15613: Re-Analysis of Landmark Statin Trials in Heart Failure Patients Using Competing Risks Methods
Introduction: To date, no large randomized trials of heart failure (HF) patients have demonstrated significant reductions in atherothrombotic cardiovascular (CV) events with statin use. Substantial competing risks from other causes of death among HF patients may prevent traditional survival analyses from detecting a benefit for statins.
Methods: We used the competing risks approach of Fine and Gray - which examines joint and simultaneous risks for diverse first events - to determine competing risks for fatal/non-fatal myocardial infarction (MI), fatal/non-fatal stroke, other CV death, and non-CV death. We pooled data for an individual-level meta-analysis of CORONA and GISSI-HF, two trials of HF patients randomized to rosuvastatin 10 mg daily vs placebo.
Results: CORONA (5011 patients, median follow-up 32.8 months) included patients age 60 or older with ischemic systolic HF whereas GISSI-HF (4574 patients, median follow-up 46.9 months) included patients over age 18 with HF of any etiology. CORONA participants were older than GISSI-HF participants and more likely to have advanced HF (NYHA class III or IV), prior MI and prior stroke. After accounting for competing risks, rosuvastatin decreased risk of MI among CORONA and GISSI-HF participants with ischemic HF (HR 0.81, 95% CI 0.66-0.99); this was borderline significant when GISSI-HF participants with non-ischemic etiologies of HF were included (HR 0.83, 95% CI 0.68-1.00). Among risk subgroups from CORONA and GISSI-HF, rosuvastatin reduced risk for MI particularly for men and participants with elevated LDL cholesterol (Figure). There were no significant differences between rosuvastatin and placebo in risks for stroke or death from other causes.
Conclusions: Rosuvastatin appears to decrease MI risk among patients with ischemic causes of heart failure, particularly men and those with elevated LDL cholesterol. Competing risks analyses may be useful in examining cohorts with substantial comorbidities.
- © 2013 by American Heart Association, Inc.